Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
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Potential for the advia centaur syphilis assay to interfere with the br (ca 27.29) assay on the advia centaur systems. this interference only occurs when the syphilis assay immediately precedes the br assay on the advia centaur advia centaur xp or advia centaur xpt systems. the advia centaur cp system is not impacted. the issue affects all current and future lots of advia centaur systems br reagents until a solution is implemented.